Performance and safety evaluation of a novel noninvasive glucose monitoring device and evaluation of the instructions for use (RSP-21)

Aim of the study

Performance and safety assessment of the P0.5 prototype and evaluation of the device’s instructions for use.

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Study description

Ten participants used the P0.5 prototype during 40 homebased measurement days, completing six sessions per day while following their normal routines. They also attended two inclinic study days with controlled glucose excursions, where measurements were taken frequently to assess performance under rapid glucose changes. The study additionally evaluated whether the device’s instructions for use supported correct and consistent operation.

Conclusions

‍The miniaturized P0.5 prototype achieved strong independent performance and demonstrated safe, user-friendly operation during extended home use.

Study registration

‍For more information, see the study registration on ClinicalTrials.gov (NCT04033042).

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